Photodynamic Therapy Using Temoporfin Before Surgery in Treating Patients With Recurrent Oral Cavity or Oropharyngeal Cancer
Primary Purpose
Recurrent Squamous Cell Carcinoma of the Lip and Oral Cavity, Recurrent Squamous Cell Carcinoma of the Oropharynx, Recurrent Verrucous Carcinoma of the Oral Cavity
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
photodynamic therapy
therapeutic conventional surgery
laboratory biomarker analysis
temoporfin
Sponsored by
About this trial
This is an interventional treatment trial for Recurrent Squamous Cell Carcinoma of the Lip and Oral Cavity
Eligibility Criteria
Inclusion Criteria:
- Eastern Cooperative Oncology Group (ECOG) performance status of =< 2
- Histologically confirmed recurrent or T2/T3/T4 squamous cell carcinoma of the oropharynx or oral cavity that are amenable to surgery
- Tumor accessible for unrestricted illumination for interstitial photodynamic therapy (PDT) (accessibility as determined by the physician)
- Life expectancy of at least 6 months in the judgment of the physician
- Blood urea nitrogen (BUN) =< upper limit of normal (ULN)
- White blood count > 3,000 per microliter or
- Absolute neutrophil count (ANC) > 1500 per microliter
- Serum calcium within normal limits; note: serum calcium will be corrected for low albumin, if necessary
- Subjects of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately
- Subject or legal representative must understand the investigational nature of this study and sign an Institutional Review Board approved written informed consent form prior to receiving any study related procedure
Exclusion Criteria:
- Subjects who have had radiotherapy within the last 3 months
- Subjects with known brain metastases should be excluded from this clinical trial
- Tumor invading a major blood vessel (such as the carotid artery)
- Tumor invading the skull base
- Subjects with ophthalmic disease
- Tumor is not clearly shown on an imaging scan/location and extension of tumor that precludes effective PDT, in the judgment of the primary investigator (PI)
- Location and extension of the tumor precludes an effective interstitial photodynamic therapy (iPDT)
- Patients with known hypersensitivity to porphyrins or with porphyria
- Has distant metastasis that decreases life expectancy to less than 6 months
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Pregnant or nursing female subjects
- Unwilling or unable to follow protocol requirements and the light exposure precautions
- Any condition which in the investigator's opinion deems the subject an unsuitable candidate to receive study drug
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment (interstitial photodynamic therapy using temoporfin)
Arm Description
Patients receive temoporfin IV over at least 6 minutes on day 1 and undergo interstitial photodynamic therapy on day 3. Within 4-6 weeks, patients undergo surgical resection.
Outcomes
Primary Outcome Measures
Frequency of adverse events, graded according to NCI CTCAE version 4.0
The frequency of toxicities will be tabulated by grade.
Secondary Outcome Measures
Light dose-volume histograms (DVH), defined as the overall light dose (joules) that was delivered to the tumor volume throughout the therapy with the light dosimetry system
Ratio of the viable/nonviable tissue in the resected tumor, ex vivo
The area of viable and necrotic tumor will be measured by the number of field of view (1 FOV = 0.196 mm^2), microscopic area using a 40x objective.
Full Information
NCT ID
NCT01718223
First Posted
October 29, 2012
Last Updated
September 2, 2014
Sponsor
Roswell Park Cancer Institute
Collaborators
National Institutes of Health (NIH), Biolitec Pharma Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT01718223
Brief Title
Photodynamic Therapy Using Temoporfin Before Surgery in Treating Patients With Recurrent Oral Cavity or Oropharyngeal Cancer
Official Title
A Pilot Study of Interstitial Photodynamic Therapy for Recurrent Squamous Cell Carcinoma of the Oropharynx and Oral Cavity
Study Type
Interventional
2. Study Status
Record Verification Date
September 2014
Overall Recruitment Status
Withdrawn
Why Stopped
implementation issues
Study Start Date
December 2013 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
August 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Roswell Park Cancer Institute
Collaborators
National Institutes of Health (NIH), Biolitec Pharma Ltd.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This pilot clinical trial studies photodynamic therapy using temoporfin before surgery in treating patients with recurrent oral cavity or oropharyngeal cancer. Photodynamic therapy uses a drug, such as temoporfin, that is absorbed by tumor cells. The drug becomes active when it is exposed to light. When the drug is active, tumor cells are killed. Giving photodynamic therapy using temoporfin before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
Detailed Description
PRIMARY OBJECTIVES:
I. To assess the toxicity of dose regimen using the Cancer Therapy Evaluation Program (CTEP) National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE version 4.0).
SECONDARY OBJECTIVES:
I. Quantify the relationship between the measured intra-tumor light dose and the pathological tumor response.
TERTIARY OBJECTIVES:
I. Simulate light dose distribution within the treated tumor. II. Immune markers.
OUTLINE:
Patients receive temoporfin intravenously (IV) over at least 6 minutes on day 1 and undergo interstitial photodynamic therapy on day 3. Within 4-6 weeks, patients undergo surgical resection.
After completion of study treatment, patients are followed for 3 years.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Squamous Cell Carcinoma of the Lip and Oral Cavity, Recurrent Squamous Cell Carcinoma of the Oropharynx, Recurrent Verrucous Carcinoma of the Oral Cavity, Stage I Squamous Cell Carcinoma of the Lip and Oral Cavity, Stage I Squamous Cell Carcinoma of the Oropharynx, Stage I Verrucous Carcinoma of the Oral Cavity, Stage II Squamous Cell Carcinoma of the Lip and Oral Cavity, Stage II Squamous Cell Carcinoma of the Oropharynx, Stage II Verrucous Carcinoma of the Oral Cavity, Tongue Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment (interstitial photodynamic therapy using temoporfin)
Arm Type
Experimental
Arm Description
Patients receive temoporfin IV over at least 6 minutes on day 1 and undergo interstitial photodynamic therapy on day 3. Within 4-6 weeks, patients undergo surgical resection.
Intervention Type
Drug
Intervention Name(s)
photodynamic therapy
Other Intervention Name(s)
Light Infusion Therapy™, PDT, therapy, photodynamic
Intervention Description
Undergo interstitial photodynamic therapy using temoporfin
Intervention Type
Procedure
Intervention Name(s)
therapeutic conventional surgery
Intervention Description
Undergo surgical resection
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Description
Correlative studies
Intervention Type
Drug
Intervention Name(s)
temoporfin
Other Intervention Name(s)
Foscan, m-tetrahydroxyphenyl-chlorin, mTHPC
Intervention Description
Undergo interstitial photodynamic therapy using temoporfin
Primary Outcome Measure Information:
Title
Frequency of adverse events, graded according to NCI CTCAE version 4.0
Description
The frequency of toxicities will be tabulated by grade.
Time Frame
Up to 30 days after surgical resection
Secondary Outcome Measure Information:
Title
Light dose-volume histograms (DVH), defined as the overall light dose (joules) that was delivered to the tumor volume throughout the therapy with the light dosimetry system
Time Frame
Day 3
Title
Ratio of the viable/nonviable tissue in the resected tumor, ex vivo
Description
The area of viable and necrotic tumor will be measured by the number of field of view (1 FOV = 0.196 mm^2), microscopic area using a 40x objective.
Time Frame
Up to 6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Eastern Cooperative Oncology Group (ECOG) performance status of =< 2
Histologically confirmed recurrent or T2/T3/T4 squamous cell carcinoma of the oropharynx or oral cavity that are amenable to surgery
Tumor accessible for unrestricted illumination for interstitial photodynamic therapy (PDT) (accessibility as determined by the physician)
Life expectancy of at least 6 months in the judgment of the physician
Blood urea nitrogen (BUN) =< upper limit of normal (ULN)
White blood count > 3,000 per microliter or
Absolute neutrophil count (ANC) > 1500 per microliter
Serum calcium within normal limits; note: serum calcium will be corrected for low albumin, if necessary
Subjects of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately
Subject or legal representative must understand the investigational nature of this study and sign an Institutional Review Board approved written informed consent form prior to receiving any study related procedure
Exclusion Criteria:
Subjects who have had radiotherapy within the last 3 months
Subjects with known brain metastases should be excluded from this clinical trial
Tumor invading a major blood vessel (such as the carotid artery)
Tumor invading the skull base
Subjects with ophthalmic disease
Tumor is not clearly shown on an imaging scan/location and extension of tumor that precludes effective PDT, in the judgment of the primary investigator (PI)
Location and extension of the tumor precludes an effective interstitial photodynamic therapy (iPDT)
Patients with known hypersensitivity to porphyrins or with porphyria
Has distant metastasis that decreases life expectancy to less than 6 months
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Pregnant or nursing female subjects
Unwilling or unable to follow protocol requirements and the light exposure precautions
Any condition which in the investigator's opinion deems the subject an unsuitable candidate to receive study drug
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hassan Arshad, MD
Organizational Affiliation
Roswell Park Cancer Institute
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Photodynamic Therapy Using Temoporfin Before Surgery in Treating Patients With Recurrent Oral Cavity or Oropharyngeal Cancer
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